3-AP in Treating Patients With Advanced Prostate Cancer

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.

Full Title of Study: “A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Detailed Description

OBJECTIVES: – Determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-AP. – Determine the toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive 3-AP IV over 2 hours on days 1-4. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for up to 1 year. PROJECTED ACCRUAL: Approximately 13-27 patients will be accrued for this study.

Interventions

  • Drug: triapine

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods: – Measurable disease – PSA level of at least 5 ng/mL with a positive bone scan – Objective evidence of progressive metastatic disease in the past 3 months defined by any of the following: – An increase in PSA value of at least 25% (minimum absolute increase of 5 ng/mL) on at least 2 successive occasions, at least 2 weeks apart – A new symptomatic lesion on bone scan – A new metastases not in bone – Growth of existing non-bone measurable metastatic disease NOTE: An increase in pain or symptoms alone without other evidence of progression, or elevation of PSA or serum alkaline phosphatase alone without evidence of metastatic disease is not sufficient – Prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure – Patients with no prior bilateral orchiectomy must have a testosterone level less than 50 ng/mL and must continue leuteinizing hormone-releasing hormone therapy while on study – No known active CNS metastases (excluding prior CNS metastases with currently stable disease after treatment ) PATIENT CHARACTERISTICS: Age – 18 and over Performance status – ECOG 0-2 Life expectancy – More than 3 months Hematopoietic – WBC at least 3,000/mm^3 – Absolute neutrophil count at least 1,500/mm^3 – Platelet count at least 100,000/mm^3 – Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic – Bilirubin no greater than 2.0 mg/dL – ALT/AST no greater than 5 times upper limit of normal – Albumin greater than 2.5 g/dL – Chronic hepatitis allowed Renal – Creatinine no greater than 2.0 mg/dL Cardiovascular – No myocardial infarction within the past 3 months – No unstable angina – No uncontrolled arrhythmias – No uncontrolled congestive heart failure Pulmonary – No dyspnea at rest Other – Nutrition adequate (caloric intake considered adequate for maintenance of weight) – Fertile patients must use effective contraception – No prior or concurrent malignancies except for non-metastatic basal cell or squamous cell skin cancer or any stage I malignancy curatively resected more than 5 years ago – No active uncontrolled infectious process – No other life-threatening illness – No peripheral neuropathy greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy – At least 2 weeks since prior biologic therapy Chemotherapy – At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered – No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy – See Disease Characteristics – At least 4 weeks since other prior hormonal therapy including any of the following: – Megestrol – Finasteride – Herbal products known to decrease PSA levels (e.g., saw palmetto and PC-SPES) – Systemic corticosteroids – At least 4 weeks since prior flutamide therapy (6 weeks for bicalutamide or nilutamide) with continued evidence of progressive disease documented by at least 1 PSA value after discontinuation Radiotherapy – At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) – At least 4 weeks since prior radiotherapy and recovered Surgery – See Disease Characteristics – At least 3 weeks since prior major surgery and recovered Other – No other concurrent investigational agents – No other concurrent anticancer treatment

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vion Pharmaceuticals
  • Overall Official(s)
    • Mario Sznol, MD, Study Chair, Vion Pharmaceuticals

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